Identity
- Trade Name
- PyroSphere CMC FDA UDI
- Generic Name
- Carpometacarpal interpositional spacer prosthesis trial FDA UDI
- Device Name
- PYROSPHERE TRIAL SZ. 40 FDA UDI
- Model / Reference
- TRL-435-40 FDA UDI
- Description
- PYROSPHERE TRIAL SZ. 40 FDA UDI
Identifiers
- Catalog Number
- TRL-435-40 FDA UDI
- Primary DI / UDI-DI
- 00885556830871 FDA UDI
- 510(k) Number
- K042690 FDA UDI
- FDA Product Code
- KYI FDA UDI
- GMDN Term
- Carpometacarpal interpositional spacer prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Carpometacarpal interpositional spacer prosthesis trial
PyroSphere CMC by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carpometacarpal interpositional spacer prosthesis trial.
- Integra® PyroSphere® — Ascension Orthopedics, Inc. · Class II
- Integra® NuGrip® — Ascension Orthopedics, Inc. · Class II
- Integra® PyroSphere® — Ascension Orthopedics, Inc. · Class II
- Integra® NuGrip® — Ascension Orthopedics, Inc. · Class II
- Integra® PyroSphere® — Ascension Orthopedics, Inc. · Class II
- Integra® — Ascension Orthopedics, Inc. · Class II
- Integra® NuGrip® — Ascension Orthopedics, Inc. · Class II
- Integra® — Ascension Orthopedics, Inc. · Class II
Cleared under the same submission
K042690 also covers:
- Ascension® PyroSphere — Ascension Orthopedics, Inc.
- Ascension® PyroSphere — Ascension Orthopedics, Inc.
- Ascension® PyroSphere — Ascension Orthopedics, Inc.
- Ascension® PyroSphere — Ascension Orthopedics, Inc.
- Ascension® PyroSphere — Ascension Orthopedics, Inc.
- Integra® PyroSphere® — Ascension Orthopedics, Inc.
- Integra® PyroSphere® — Ascension Orthopedics, Inc.
- Integra® PyroSphere® — Ascension Orthopedics, Inc.
- Integra® PyroSphere® — Ascension Orthopedics, Inc.
- Integra® PyroSphere® — Ascension Orthopedics, Inc.
- PyroSphere CMC — Smith & Nephew, Inc.
- PyroSphere CMC — Smith & Nephew, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 32b496d4-54ca-4df5-a3e7-12a82a102a60 38 fields · synced Jun 8, 2026